Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw

Femoral Neck Fractures Clinical Trial

Official title:

Post Operative Pain Control Among Intrathecal 0.1 mg Morphine, Femoral Nerve Block, or Periarticular Infiltration of 20 mL of 0.25% Bupivacaine in Patients Post Intramedullary Hip Screw

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01219088
• Other study ID #: Si392/2010
• Status: Recruiting
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: August 3, 2011
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2011
• Source: Mahidol University
• Contact: Thitima Chinachoti, M.D.
• Phone: 66813082438
• Email: sitci35[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Falls are a common problem in elderly patients resulting fractured femur, which require early operation. Adequate postoperative pain control will provide good recovery. The investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

Description:

Study methods :

Every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups

1. Controlled group : spinal anesthesia alone

2. Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia

3. Spinal anesthesia plus 0.1 mg morphine intrathecally

4. Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

All patients will receive postoperative intravenous patient controlled analgesia (IV PCA) morphine for 48 hours.

Data collection

1. Demographic data

2. Pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (VASS)

3. Patient global assessment and patient satisfactory VASS at 24 and 48 hours postoperative

4. The amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90 years old

• good consciousness, well co-operated, can use PCA machine

• ASA class 1-3

• no contraindication of spinal anesthesia

• accept for spinal anesthesia

• body weight > 30 kg

• BMI 20-35 kg/m2

• no history of research-drug allergy

Exclusion Criteria:

• previous history of hip surgery (the same side)

• pathological fractured such as severe infection, bone cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures

Intervention

Drug:
• Bupivacaine, morphine
1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of morphine consumption.		24 hours postoperative	Yes
Secondary	Efficacy of pain control	Efficacy of pain control measured by; The amout of morphine consumption; Visual analogue pain scale; Patient satisfaction by patient global assessment; Incidences of adverse events : nausea, vomiting, pruritus	48 hours postoperative	Yes